FDA Approves New Drug Treatment for Type 2 DiabetesThe U.S. Food and Drug Administration today approved Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults. The medication is intended to be used with diet and exercise to control high blood sugar levels.

The hormone insulin keeps blood sugar (glucose) levels within a narrow range in people who don’t have diabetes. People with Type 2 diabetes are either resistant to insulin or do not produce enough insulin to maintain normal blood sugar levels.

Onglyza is in a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors which stimulate the pancreas to make more insulin after eating a meal.

“Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes,” said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease.”

The most common side effects observed with Onglyza are upper respiratory tract infection, urinary tract infection, and headache. Other side effects include allergic-like reactions such as rash and hives.

Approval of Onglyza was primarily based on the results of eight clinical trials. The application seeking FDA approval was submitted before December 2008 when the agency recommended that manufacturers of new diabetes drugs carefully design and evaluate their clinical trials for cardiovascular safety. Although Onglyza was not associated with an increased risk for cardiovascular events in patients who were mainly at low risk for these events, the FDA is requiring a postmarket study that will specifically evaluate cardiovascular safety in a higher risk population.

Onglyza is manufactured by Bristol-Myers Squibb Co. of Princeton, N.J., and marketed by Bristol-Myers and AstraZeneca Pharmaceuticals LP, of Wilmington, Del.

Abbott and FDA notified healthcare professionals of the national Class 1 recall of three lots of POWERSAIL Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints that the distal shaft of the catheter exhibited damage. The damage may cause a leak of contrast material during use, which could lead to catheter functional failures and clinical consequences, including air embolism and myocardial infarction, which has the potential to lead to death.

Customers with questions or concerns should contact their Abbott Vascular Representative or call the company at 1-800-227-9902. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

Read the complete MedWatch 2009 Safety summary, including a link to the firm press release, at:

Abbott and FDA notified healthcare professionals of the national Class 1 recall of three lots of POWERSAIL Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints that the distal shaft of the catheter exhibited damage. The damage may cause a leak of contrast material during use, which could lead to catheter functional failures and clinical consequences, including air embolism and myocardial infarction, which has the potential to lead to death.

Customers with questions or concerns should contact their Abbott Vascular Representative or call the company at 1-800-227-9902. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

[07/30/2009 - Press Release - Abbott]

Recall -- Firm Press Release FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

FOR IMMEDIATE RELEASE - ABBOTT PARK, Ill. - July 28, 2009 - Abbott has conducted a voluntary recall of three lots of POWERSAIL® Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints (one from each lot) that the distal shaft of the catheter exhibited damage. While the issue could be detected and avoided during the preparation for use of the product, it may cause a leak of contrast material during use, which could lead to catheter functional failures and clinical consequences, including air embolism and myocardial infarction, which has the potential to lead to death.

Abbott Vascular's sales representatives contacted all customers affected by this action and instructed them to cease use of any units from the part numbers and lot numbers listed below. All outstanding units are in the company's possession or are in transit. Patients who have already been treated are not affected by this action.

Three out of the four complaints of distal shaft damage resulted in no adverse patient effects. One complaint reported that the patient had evidence of a post-procedural myocardial infarction. Subsequently, the patient was reported to be doing well.

The United States Food and Drug Administration (FDA) has been apprised of this action, and it has classified this action as a Class I recall.

The POWERSAIL Coronary Dilatation Catheter is distributed for prescription use only to approved U.S. and international health care organizations. Affected devices can be identified by the part number and lot number combinations shown above.

Customers with questions or concerns should contact their Abbott Vascular Representative or call the company at 1-800-227-9902.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

FDA notified healthcare professionals of the approval of the first single-ingredient oral colchicine product, Colcrys, for the treatment of familial Mediterranean fever (FMF) and acute gout flares and of two previously uncharacterized safety concerns associated with the use of colchicine. Oral colchicine has been used for many years as an unapproved drug with no FDA-approved prescribing information, dosage recommendations, or drug interaction warnings.

FDA analyzed safety data for colchicine from adverse events reported to the Agency, the published literature, and company-sponsored pharmacokinetic and drug interaction studies. This analysis revealed cases of fatal colchicine toxicity reported in certain patients taking standard therapeutic doses of colchicine and concomitant medications that interact with colchicine, such as clarithromycin. These reports suggest that drug interactions affecting the gastrointestinal absorption and/or hepatic metabolism of colchicine play a central role in the development of colchicine toxicity. Data submitted supporting the safety and efficacy of Colcrys in acute gout flares demonstrated that a substantially lower dose of colchicine was as effective as the higher dose traditionally used. Moreover, patients receiving the lower dose experienced significantly fewer adverse events compared to the higher dose.

Based on this information, FDA has included important safety considerations in the approved prescribing information to assure safe use of Colcrys and is providing background information, a data summary and recommendations in this alert.

Read the complete MedWatch Safety summary, including a link the the Information for Healthcare Professionals page with a data summary and patient management recommendations, at:

[Posted 07/30/2009] FDA notified healthcare professionals of the approval of the first single-ingredient oral colchicine product, Colcrys, for the treatment of familial Mediterranean fever (FMF) and acute gout flares and of two previously uncharacterized safety concerns associated with the use of colchicine. Oral colchicine has been used for many years as an unapproved drug with no FDA-approved prescribing information, dosage recommendations, or drug interaction warnings.

FDA analyzed safety data for colchicine from adverse events reported to the Agency, the published literature, and company-sponsored pharmacokinetic and drug interaction studies. This analysis revealed cases of fatal colchicine toxicity reported in certain patients taking standard therapeutic doses of colchicine and concomitant medications that interact with colchicine, such as clarithromycin. These reports suggest that drug interactions affecting the gastrointestinal absorption and/or hepatic metabolism of colchicine play a central role in the development of colchicine toxicity. Data submitted supporting the safety and efficacy of Colcrys in acute gout flares demonstrated that a substantially lower dose of colchicine was as effective as the higher dose traditionally used. Moreover, patients receiving the lower dose experienced significantly fewer adverse events compared to the higher dose.

Based on this information, FDA has included important safety considerations in the approved prescribing information to assure safe use of Colcrys and is providing background information, a data summary and recommendations in this alert.

[07/30/2009 - Information for Healthcare Professionals - FDA]

Information for Healthcare Professionals: New Safety Information for Colchicine (marketed as Colcrys)

FDA ALERT [07/30/2009]: FDA has now approved the first single-ingredient oral colchicine product, Colcrys, for the treatment of familial Mediterranean fever (FMF) and acute gout flares. Oral colchicine has been used for many years as an unapproved drug with no FDA-approved prescribing information, dosage recommendations, or drug interaction warnings.During the drug application review, FDA identified two previously uncharacterized safety concerns associated with the use of colchicine (marketed as Colcrys).

First, FDA analyzed safety data for colchicine from adverse events reported to the Agency, the published literature, and company-sponsored pharmacokinetic and drug interaction studies. This analysis revealed cases of fatal colchicine toxicity reported in certain patients taking standard therapeutic doses of colchicine and concomitant medications that interact with colchicine, such as clarithromycin. These reports suggest that drug interactions affecting the gastrointestinal absorption and/or hepatic metabolism of colchicine play a central role in the development of colchicine toxicity.

Based on this information, FDA is highlighting important safety considerations found in the approved prescribing information to assure safe use of Colcrys.

FDA recommends:

Healthcare professionals not use P-glycoprotein (P-gp) or strong CYP3A4 inhibitors in patients with renal or hepatic impairment who are currently taking colchicine. Healthcare professionals consider a dose reduction or interruption of colchicine treatment in patients with normal renal and hepatic function if treatment with a P-gp or a strong CYP3A4 inhibitor is required. Healthcare professionals prescribe the FDA-approved Colcrys dose for the treatment of acute gout flares: 1.2 mg followed by 0.6mg in 1 hour (total 1.8mg). Healthcare professionals refer to Colcrys’ approved prescribing information for specific dosing recommendations and additional drug interaction information. Patients review the Medication Guide for important safety information This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.To report any unexpected adverse or serious events associated with the use of this drug, please contact the FDA MedWatch programusing the information at the bottom of this page.

Be aware that there is now an FDA-approved single-ingredient colchicine product, Colcrys Understand that the recommended dose of Colcrys (colchicine) for Familial Mediterranean Fever (FMF) and acute gout flares are different Be aware that concomitant use of P-gp and strong CYP3A4 inhibitors may cause severe drug interactions with colchicine, including death Evaluate patients’ underlying susceptibility for colchicine toxicity due to renal and hepatic impairment or age Understand that concomitant use of colchicine and P-gp or strong CYP3A4 inhibitors is contraindicated in patients with renal or hepatic impairment. Be aware that Colcrys has a Medication Guide and urge patients, their families, and caregivers to review the Medication Guide carefully Inform patients who are taking colchicine to check with healthcare professionals before taking any new medicine Information for patients, family members, and caregivers:

Understand that colchicine (Colcrys) is not a pain medication and should not be used for other causes of pain Understand that life-threatening and fatal drug interactions can occur with Colcrys if it is given with certain medications. These interactions can occur even at prescribed Colcrys doses, and with medications that are given for a limited time, such as antibiotics Review the Medication Guide that accompanies Colcrys. Discuss with healthcare professionals all medications being taken and check with them before starting any new medications Avoid consuming grapefruit and grapefruit juice while using colchicine Pay close attention for any signs or symptoms of colchicine toxicity such as muscle weakness or pain, numbness or tingling in the fingers or toes, unusual bleeding or bruising, severe diarrhea or vomiting, feeling weak or tired, increased infections, and pale or gray color of the lips, tongue, or palms of hands. If any of these symptoms occur, seek medical attention right away Background and Data Summary: Severe Drug InteractionsDuring the drug application review, FDA analyzed safety data for colchicine-related deaths described in the published literature, adverse events reported to FDA’s Adverse Event Reporting System (AERS), and company-sponsored pharmacokinetic and drug interaction studies. The analysis found 169 deaths associated with the use of oral colchicine.

Of the 169 deaths, 117 were not reported as overdoses; i.e., the majority of reported deaths had colchicine doses within the therapeutic range of less than or equal to 2 mg per day. The reported death cases did not contain information regarding patients’ renal or hepatic function. Sixty of the 117 reported deaths (51%) involved patients who were concomitantly using clarithromycin.* These reports suggest alterations in the pharmacokinetics of colchicine played a central role in the development of toxicity.

The pharmacokinetics of colchicine may be affected in several ways. The absorption of colchicine from the gastrointestinal tract is thought to be limited by the multidrug resistance efflux transporter P-glycoprotein (P-gp). Additionally, colchicine is a substrate of intestinal and hepatic cytochrome P450 3A4 (CYP3A4), which catalyzes demethylation of colchicine to inactive metabolites. Colchicine is primarily eliminated by hepatobiliary excretion through the stool. Renal excretion accounts for 10-20% of colchicine elimination in patients with normal renal function.

Consistent with the current understanding of colchicine metabolism, certain drugs increase the potential for colchicine toxicity via modulation of P-gp and CYP3A4 activity. Life-threatening and fatal drug interactions have been reported in patients treated with colchicine when P-gp and strong CYP3A4 inhibitors, particularly clarithromycin, were also being used. In the majority of cases, the doses of colchicine were within the therapeutic range.

Fatal and non-fatal cases of colchicine toxicity have also been reported in the literature with concomitant use of other CYP3A4 and P-gp inhibitors, such as cyclosporine, erythromycin, and calcium channel antagonists such as verapamil and diltiazem. Other examples of P-gp and strong CYP3A4 inhibitors include telithromycin, ketoconazole, itraconazole, HIV protease inhibitors, and nefazodone. Toxicity has also been reported in a patient who began to regularly consume a liter of grapefruit juice daily while being treated chronically with colchicine. Additionally, cases of myopathy and/or rhabdomyolysis in patients receiving colchicine have been reported with concomitant use of statins, fenofibrate/gemfibrozil, cyclosporine, or digoxin.

Based on this information, FDA concludes there is a risk for severe drug interactions in certain patients treated with colchicine and concomitant P-gp or strong CYP3A4 inhibitors. FDA recommends that P-gp or strong CYP3A4 inhibitors not be used in patients with renal or hepatic impairment who are currently taking colchicine. Furthermore, FDA recommends that healthcare professionals consider a dose reduction or interruption of colchicine in patients with normal renal and hepatic function if treatment with a P-gp or a strong CYP3A4 inhibitor is required. The FDA-approved prescribing information for Colcrys contains recommended dosage adjustments.

* The FDA approved prescribing information for clarithromycin (marketed as Biaxin, Biaxin Filmtab, Biaxin XL) was updated in 2005 and 2006 to include this warning: There have been post-marketing reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Deaths have been reported in some such patients.

Data Summary: Acute Gout

For the treatment of acute gout flares, medical texts typically recommend that patients take orally 1.2mg of colchicine followed by 0.6mg every hour until the flare resolves or until gastrointestinal toxicity occurs. However, adequate studies to determine the optimal dose of colchicine in acute gout flares have never been conducted. As part of the application for approval, the manufacturer of Colcrys submitted data from a clinical trial to evaluate the safety and efficacy of a low-dose regimen of oral colchicine for treatment of acute gout flares compared to the traditional high-dose regimen.

The trial was a multicenter, randomized, double-blind, placebo-controlled trial of patients meeting American College of Rheumatology criteria for gout who were assigned to one of three treatment groups within 12 hours of a gout flare, as follows:

These findings suggest that prior use of high-dose colchicine may have exposed patients to increased toxicity with no greater efficacy than the low-dose regimen. Based on this trial, FDA recommends that healthcare professionals prescribe the approved Colcrys dose of 1.2mg at onset of acute gout flare followed by 0.6mg in 1 hour, for a total of 1.8mg, and carefully consider the need for additional subsequent dosing. Healthcare professionals should also monitor patients for signs and symptoms of colchicine toxicity.

Public Health Advisory: The FDA recommends that consumers should not use body building products marketed as containing steroids or steroid-like substances7/28/2009

The FDA is notifying the public about new safety information concerning products marketed for body building and increasing muscle mass. The FDA has sent a Warning Letter to a manufacturer of body building supplements that claim to contain steroid-like ingredients, but in fact contain synthetic steroids. The products named in the Warning Letter are marketed by American Cellular Laboratories, Inc., and include “TREN-Xtreme,” “MASS Xtreme,” “ESTRO Xtreme,” “AH-89-Xtreme,” “HMG Xtreme,” “MMA-3 Xtreme,” “VNS-9 Xtreme,” and “TT-40-Xtreme.”

The FDA has received reports of serious adverse events associated with the use of these products and other similar products. Products like these are frequently marketed as alternatives to anabolic steroids for increasing muscle mass and strength and are sold both online and in retail stores. They are often promoted to athletes to improve sports performance and to aid in recovery from training and sporting events. Although products containing synthetic steroids are frequently marketed as dietary supplements, they are NOT dietary supplements, but instead are unapproved new drugs that have not been reviewed by the FDA for safety and effectiveness.

Adverse event reports received by the FDA for body building products that are labeled to contain steroids or steroid alternatives involve men (ages 22-55) and include cases of serious liver injury, stroke, kidney failure and pulmonary embolism (blockage of an artery in the lung).

Due to the potentially serious health risks associated with using these types of products, the FDA recommends that consumers immediately stop using all body building products that claim to contain steroids or steroid-like substances. Consumers should consult their health care professional if they are experiencing symptoms possibly associated with these products, particularly nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, jaundice (yellowing of the skin or whites of the eyes) or brown/discolored urine. The FDA also recommends that consumers talk with their health care professional about any body building supplements they are taking or planning to take, particularly if they are uncertain about a product’s ingredients.

Health care professionals are advised to ask their patients about any over-the-counter products they may be using, including products marketed as dietary supplements. Additionally, health care professionals should be alert to patients presenting with the warning signs that may be associated with the use of steroids or steroid-like substances, including liver injury, kidney failure, stroke, and hormone-associated adverse effects, such as blood clots, including pulmonary embolism and deep vein thrombosis.

Health care professionals and consumers are encouraged to report any adverse events related to the use of these products to FDA's MedWatch Adverse Event Reporting program, either online, by regular mail or by fax, using the contact information at the bottom of this page.

For more details about these products see FDA’s Consumer Information piece (Consumer Update)Warning on Body Building Products Marketed as Containing Steroids or Steroid-Like Substances.

FDA NEWS RELEASEFor Immediate Release: July 28, 2009

Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov Consumer Inquiries: 888-INFO-FDAFDA Warns Consumers Not to Use Body Building Products Marketed as Containing Steroids or Steroid-Like SubstancesAgency issues Warning Letter to American Cellular Laboratories for marketing and distributing potentially harmful steroid-containing productsThe U.S. Food and Drug Administration today issued a Public Health Advisory (PHA) warning consumers to stop using body building products that are represented as containing steroids or steroid-like substances. Many of these products are marketed as dietary supplements.

The agency also issued a Warning Letter to American Cellular Laboratories Inc. for marketing and distributing body building products containing synthetic steroid substances. Although these products are marketed as dietary supplements, they are not dietary supplements, but instead are unapproved and misbranded drugs.

The PHA notifies consumers and health care professionals that the FDA has received reports of serious adverse events associated with the use of body building products that claim to contain steroids or steroid-like substances. Those adverse events include cases of serious liver injury, stroke, kidney failure and pulmonary embolism (artery blockage in the lung). The PHA also advises consumers to stop taking body building products from any manufacturer that claim to contain steroid-like substances or to enhance or diminish androgen-, estrogen-, or progestin-like effects in the body.

The FDA has received five adverse event reports, including serious liver injury, in men taking products marketed as dietary supplements by American Cellular Laboratories including TREN-Xtreme and MASS Xtreme. Acute liver injury is generally known to be a possible side effect of using products that contain anabolic steroids. Some of the cases resulted in hospitalization, but there were no reports of death or acute liver failure.

“Products marketed for body building and claiming to contain steroids or steroid-like substances are illegal and potentially quite dangerous,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “The FDA is taking enforcement action today to protect the public.”

The products listed in the Warning Letter to American Cellular Laboratories Inc., include “TREN-Xtreme,” “MASS Xtreme,” “ESTRO Xtreme,” “AH-89-Xtreme,” “HMG Xtreme,” “MMA-3 Xtreme,” “VNS-9 Xtreme,” and “TT-40-Xtreme,” and are sold on the Internet and in some stores. These products, which claim to contain steroid-like ingredients but in fact contain synthetic steroid substances, are unapproved new drugs because they are not generally recognized as safe and effective. In addition, the products are misbranded because the label is misleading and does not provide adequate directions for use.

Consumers taking body building supplements that claim to contain steroids or steroid-like substances should stop taking them immediately. Consumers should also consult a health care professional if they suspect they are experiencing problems associated with the products. Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these types of products to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.